Method and composition for improving fertility health in female and male animals and humans

ABSTRACT

In a new pharmaceutical combination, the herb,  Vitex agnus - castus  (chasteberry), enhances hormone balance by increasing progesterone release and, therefore, ovulation frequency. The antioxidants, green tea, vitamin E, and selenium, improve overall reproductive health. L-arginine, an amino acid, stimulates the reproductive organs by improving circulation. Folic acid, vitamins B6 and B12, iron, zinc and magnesium help promote womens&#39; fertility. Sperms are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. Vitamins C and E, coenzyme Q10 and selenium are all potent antioxidants that help improve sperm counts and quality. Ferulic acid, an antioxidant found in Dong quai, also improves sperm quality. Zinc and B vitamins (B6, B12 and folate) are critical nutrients in male reproductive systems for hormone metabolism, sperm formation and motility. The amino acid, L-carnitine, promotes formation of healthy sperm.

This application is a divisional of application Ser. No. 09/742,412 filed Dec. 22, 2000 now U.S. Pat. Nos. 6,497,885.

BACKGROUND OF THE INVENTION

Because of delayed child bearing, unhealthy diets and use of tobacco, caffeine, alcohol, drugs and environmental contaminants, difficulties in conceiving have been experienced.

Needs exist for pharmaceutical compounds that improve fertility in both women and men.

SUMMARY OF THE INVENTION

This invention provides combinations of bioeffecting compounds for promoting fertility in men and women. The combinations include nutritional components that benefit fertility health. All the components have been studied separately, to determine their individual efficacy. The invention provides the first products to put these components together synergistically in women's and men's formulations.

As many as 15% of couples in the U.S. have difficulty conceiving a child. In about one third of these cases, it is the man that is infertile; in another third, the female has fertility issues. The remaining is due to a combination of male and female fertility issues, or unknown causes. In many of these cases, causes of infertility are treatable. Nutritional and lifestyle changes should be the first step to increasing chances for conception. Smoking and caffeine, drug and alcohol consumption, environmental toxicants, and stress are related to infertility in men and women. Reproductive organs are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. A balanced, nutritional diet, and nutritional supplements with high antioxidant content can help reverse some of that damage. In women, hormone balance is critical to monthly ovulation and development of the corpus luteum (an ovarian follicle that release progesterone after release of the egg to prepare the uterus for implantation).

These and further and other objects and features of the invention are apparent in the disclosure, which include the above ongoing written specification with the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention provides combinations of beneficial bioeffecting compounds for promoting fertility in women. The invention provides a scientifically validated herbal/nutritional blend for women to improve infertility by helping to regulate the menstrual cycle and correct hormone imbalance (corpus luteum insufficiency) without increased chances of multiple births associated with drug therapy. The combination of amino acids, herbs, vitamins and minerals improves overall health and helps with many of the deficiencies that decrease fertility.

The herb, Vitex agnus-castus (chasteberry), enhances hormone balance by increasing progesterone release and, therefore, ovulation frequency. The antioxidants, green tea, vitamin E, and selenium, improve overall reproductive health. L-arginine, an amino acid, stimulates the reproductive organs by improving circulation. Folic acid, vitamins B6 and B12, iron, zinc and magnesium help promote womens' fertility.

The invention provides combinations of beneficial bioeffecting compounds for promoting fertility in men. Sperms are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. Vitamins C and E, coenzyme Q10 and selenium are all potent antioxidants that help improve sperm counts and quality. Ferulic acid, an antioxidant found in Dong quai, also improves sperm quality. Zinc and B vitamins (B6, B12 and folate) are critical nutrients in male reproductive systems for hormone metabolism, sperm formation and motility. The amino acid, L-carnitine, promotes formation of healthy sperm.

The invention provides synergistic action of the combinations.

The two dietary supplements in male and female formulas are useful for men and women. Preferably, the distinct combinations are taken by both members of a couple in which the female age is between 21 and 46. The distinct combinations are useful for couples who have tried for 6 months or more, up to three years, to become pregnant without success. Preferably, patients take 2-4 capsules per day of the distinct formulas for three months. In women it is useful to record their basal temperature daily using thermometers and charts and to have their blood drawn for progesterone analysis at day 18-22 of the first menstrual cycle prior to taking the supplement. For men, it is useful to submit a sperm sample at the same time for analysis of count and motility. Prior to submitting sperm samples, 2-4 days abstinence is suggested for best results. No fevers over 101 degrees in the three months prior to taking the new combinations should be encountered. It is useful to repeat the analyses during the fourth menstrual cycle of the study. The first month is needed to develop baselines, followed by three months of taking the combinations product or placebo.

Preferred ranges of the combinations considered in percent by weight are:

Components Minimum % Maximum % Women's formula Vitex (chasteberry) 2 10 L-arginine 40 60 Green tea 5 20 Vitamin e 5 20 Selenium .01  1 Vitamins B6, B12 .01  1 Folic acid .01  1 Iron .1  5 Magnesium 10 40 Zinc 1  5 Men's Formula L-carnitine 40 70 Ferulic acid in Dong Quai .1 10 Vitamins C and E 10 40 Coenzyme coQ10 .1  5 Selenium .01  1 Zinc .1 10 B vitamins .001  1

Acceptable ranges of womens' and mens' formulations are:

Components Minimum % Maximum % Women's Formula 1 20 Vitex (chasteberry) 20 70 L-arginine 0 30 Green tea 0 30 Vitamin E 0.1 30 Selenium 0  2 Vitamins B6, B12 0  2 Folic acid 0  1 Iron 0  7 Magnesium 5 50 Zinc 0 10 Men's Formula L-carnitine 20 80 Ferulic acid in Dong Quai 0 20 Vitamins C and E .01 40 Coenzyme coQ10 .01 10 Selenium 0  3 Zinc 0 15 B vitamins 0  5

Examples of useful formulations in percent by weight are:

Components Women's formula Vitex (chasteberry)  5 L-arginiue  50 Green tea  11 Vitamin B  11 Selenium   .6 Vitamins B6, B12   .38 Folic acid   .02 Iron  1 Magnesium  20 Zinc  1 100% Men's Formula L-carnitine  60 Ferulic acid in Dong Quad  6 Vitamins C and B  30 Coenzyme coQ10  1 Selenium  6 Zinc  2 B vitamins  4 100%

While the invention has been described with references to specific embodiments, modifications and variations of the invention may be constructed without departing from the scope of the invention, which is defined in the following claims. 

1. A pharmaceutical composition having fertility promoting activity in males comprising components present in the proportion in parts by weight of about 20 to 80% L-carnitine, about 5 to 30% vitamins C and E, about 0.1 to 10% coenzyme Q10, about 0.001 to 1% selenium, about 0.2 to 20% ferulic acid, about 0.1 to 2% zinc, and about 0.001 to 1% B vitamins.
 2. A pharmaceutical composition having fertility promoting activity in males comprising components present in the proportion in parts by weight of about 10 to 80% L-carnitine, about 5 to 50% vitamins C and E, about 0.1 to 15% coenzyme Q10, about 0.001 to 1% selenium, about 0.2 to 20% ferulic acid, about0.1 to 15% zinc, and about 0.001 to 1% B vitamins.
 3. The pharmaceutical composition of claim 2, further comprising components present in the proportion in parts by weight of about 60% L-carnitine, about 25% vitamins C and E, about 6% ferulic acid, about 5% zinc and B vitamins, about 5% coenzyme Q10, and about 0.6% selenium. 